PAG · Class II · 21 CFR 878.3300

FDA Product Code PAG: Mesh, Surgical, Non-synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

Transvaginal Surgical Repair Of Female Stress Urinary Incontinence (sui) Due To Intrinsic Sphincter Deficiency (isd) And/or Urethral Hypermobility.

Leading manufacturers include Cook Biotech, Inc., Brennen Medical, Inc. and C.R. Bard, Inc..

9
Total
9
Cleared
57d
Avg days
1998
Since

FDA 510(k) Cleared Mesh, Surgical, Non-synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator Devices (Product Code PAG)

9 devices
1–9 of 9
Cleared Jul 10, 2009
COOK UROLOGICAL GRAFT
K090688
Cook Biotech, Inc.
Gastroenterology & Urology · 116d
Cleared Jun 17, 2005
AMS COLLAGEN DERMAL MATRIX
K050445
American Medical Systems, Inc.
General & Plastic Surgery · 115d
Cleared Nov 09, 2004
PELVILACE TRANSOBTURATOR BIOURETHRAL SUPPORT SYSTEM (PELVILACE TO SYSTEM)
K042949
C.R. Bard, Inc.
Gastroenterology & Urology · 14d
Cleared May 15, 2003
BARD INNERLACE BIOURETHRAL SUPPORT SYSTEM
K031295
C.R. Bard, Inc.
Gastroenterology & Urology · 22d
Cleared Mar 07, 2003
MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX
K030460
Brennen Medical, Inc.
Gastroenterology & Urology · 23d
Cleared Apr 09, 2002
STRATASIS SLING KIT
K020654
Cook Biotech, Inc.
Gastroenterology & Urology · 40d
Cleared Nov 05, 1999
MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX
K993459
Advanced Uroscience, Inc.
Gastroenterology & Urology · 23d
Cleared Sep 23, 1999
SURGISIS SLING
K992159
Cook Biotech, Inc.
General & Plastic Surgery · 90d
Cleared Sep 22, 1998
BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX
K982403
Brennen Medical, Inc.
Gastroenterology & Urology · 74d

About Product Code PAG - Regulatory Context